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Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices regularization in Brazil announced to fight the new Coronavirus

Date: 03/21/2020

ANVISA published yesterday RDC 349/2020 regarding temporary procedures for requests for the regularization of personal protective equipments, pulmonary ventilator medical equipments and other medical devices identified as strategic by ANVISA due to the international public health emergency resulting from the new Coronavirus.

Our team prepared a few highlights with important changes:

* For situations in which the manufacturing company does not have the Good Manufacturing Practices Certification issued by ANVISA, Medical Device Single Audit Program (MDSAP) or ISO 13485 Quality Management System Certification will be exceptionally accepted.

* The proof of registration, free trade certificate or equivalent document, can be replaced by a simple statement issued by the Legal and Technical Responsible of the requesting company informing that the product in question is regulated and marketed in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF) .

* Exceptionally, products covered by this Resolution are exempt from certification under the Brazilian Conformity Assessment System (SBAC).

* Registrations granted under the terms of the Resolution will be valid for 1 (one) year from the publication date in the Federal Official Gazette.

* For products subject to this Resolution, necessary declarations for Cadastro and Notification petitions are exempt from consularization or apostille.

* Requests for medical devices’ registration referred to in this Resolution will be analyzed in priority, overriding the chronological criteria.

Regularization may be granted in accordance with this Resolution, when the indication of use is identified to preventing or treating diseases caused by the new Coronavirus (COVID-19). The Resolution comes into force immediately and will be valid for 180 days.

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DOMO Salute Team

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